Director, GMP Quality Assurance

Director, GMP Quality Assurance

Hybrid – Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office 3 days/week. Open to remote for non-local candidates.

The Director of GMP Quality Assurance, reporting to the Senior Director of GMP Quality, will be responsible for providing quality oversight for Oruka's clinical development programs and manufacturing. You will be responsible to ensure Oruka's programs are advanced through the development pipeline in compliance with phase-appropriate regulatory requirements, applicable guidelines, and industry best practices. You have a strong background in GMP quality and manufacturing of biologics, with an emphasis on external manufacturing CDMO interaction and partnership.

You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment. You are a hands on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers.

Key Responsibilities:

• Provide GMP quality support and guidance for Oruka's CMC programs, ensuring compliance with applicable GxP regulations and guidelines.
• Support the negotiation, implementation, and maintenance of quality agreements with GMP suppliers.
• Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation.
• Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
• Review change controls, CAPAs, and OOS/OOT investigations in collaboration with internal and external stakeholders.
• Perform or support lot disposition activities.
• Ensure GMP quality documentation is appropriately archived and readily retrievable.
• Investigate and assess quality events such as product complaints and temperature excursions, and manage associated follow-up actions.
• Contribute to the development and maintenance of Oruka's Quality Management System (QMS), including authoring and reviewing SOPs and quality procedures as needed.
• Review and approve clinical product labeling, ensure proper controls in place across label management lifecycle.
• Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives.
• Support inspection readiness activities for both Oruka and its GMP suppliers.
• Provide GMP quality review and input for regulatory submissions and agency responses.
• Escalate quality risks and compliance issues appropriately and support risk-based decision making.
• Promote a culture of quality and continuous improvement across the organization.
• Approximately 15–20% travel (domestic and international) to GMP suppliers and Oruka offices.

Qualifications:

Required:

• Bachelor's degree in a scientific field with a minimum of 10 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required.
• In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
• Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
• Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges.
• Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff.
• Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.

Preferred:

• Experience supporting the onboarding and oversight of new GMP vendors or CDMOs.
• Prior experience contributing to the build-out or enhancement of a QMS in a development-stage company.
• Experience with visual management dashboards (Excel/Smartsheet).
• Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory…